Student research at Salisbury University has become one of the distinguishing characteristics of our mission and has brought us national recognition. The IRB/Committee on Human Research strongly supports student research so long as it is conceived and carried out in a way that insures the rights of human subjects are protected.
The Committee would like to remind faculty and students alike that any research undertaken by students as part of or related to University courses or activities is subject to review by the committee. That is our charge as mandated by federal statute, the University System of Maryland and our own ethical responsibilities as committee members. (Code of Federal Regulations, Part 46, Title 45 and University System of Maryland Policy on Human Subjects: 105.0 IV-2.10)
In the last several years, the increased number and variety of undergraduate and graduate student protocols involving human subjects and full committee review have greatly increased and have caused some problems both for the students and the committee. Understandably, it takes time to identify, develop and propose a protocol and it takes the committee a fair amount of time to work through these protocols. This has created a “crunch” often near the end of the semester that has left students and committee members increasingly frustrated. As such, this section of the website offers considerations when preparing an IRB application.
Please keep the following points in mind when working on research proposals for IRB review:
All research must be conducted within the guidelines set out for the Protection of Human Subjects. You are responsible for making sure the IRB application is completed in its entirety and for responding to any questions sent to you by the committee members. Failure to do this will delay your research or prohibit it from being completed, which would in turn affect your grade in your class.
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I need IRB approval, now what?
See decision tree
What happens at each level of review?
Exempt: for all exempt applications, one committee member is assigned to review the application. After this review, if the committee member has no questions, the application is approved and research can begin. If the committee member does have questions, these will be sent back to the Principal Investigator (PI) listed on the application. The PI needs to submit a response for review prior to approval being granted.
Expedited: for all expedited applications, two committee members are assigned to review the application. After this review, if the committee members have no questions, the application is approved and research can begin. If the committee members do have questions, these will be sent back to the PI(s) listed on the application. The PI(s) needs to submit a response for review prior to approval being granted. Both committee members must agree and sign off on the application before approval can be granted and the research can begin.
Full: for all full review applications, the entire committee is sent the application to review prior to the stated meeting date. At the meeting, the researcher(s)involved in the project must be present and will be asked to give a summary of the application and respond to questions by the committee. After the committee has asked all of the questions they have, the researchers are asked to leave the room while the committee deliberates. If all questions have been answered satisfactorily, approval will be given. If there are unanswered questions, the researchers will be given a list of points to clarify and re-submit. These will be discussed with the researchers prior to the ending of the meeting. The submitted responses are sent out to the committee as a whole for review. If all points have been answered satisfactorily, approval will be given. If they have not, the question and response process continues until all issues are resolved.
What key things are looked for in an IRB review? (this does not guarantee there won't still be questions from the committee)
Here are a few things at which the committee looks closely: checklist
What are the IRB deadlines?
The Committee requires two weeks to review and respond to Exempt or Expedited protocols. As such, these protocols need to be submitted at least three weeks prior to the planned start of the research in order to leave time for comments and revisions, if necessary.
Full Committee reviews require submission at least two weeks prior to the scheduled IRB meeting date. All listed researchers are required to attend the IRB meeting for full reviews. Researchers who need to follow a modified timeline should contact the IRB Committee Chair to discuss this.
A note about reviews over breaks (Thanksgiving, Winter Break, Spring Break, and Summer): the IRB committee is made up of faculty and therefore we cannot guarantee that applications will be reviewed following the stated timelines above. Once contracts end in June, no IRB applications will be reviewed again until contracts begin in August. There are no full committee reviews scheduled during these times. Please plan accordingly.
To whom do I send my IRB application?
All IRB applications (regardless of level of review, continuations, or amendments) are to be sent via e-mail to email@example.com. This will ensure that your application is sent to the appropriate committee member(s).
What if I need help preparing my study?
The IRB is here to make sure that human subjects are protected during the research study; we do not assist researchers with the development of their studies, this is the job of your faculty advisor. However, there are some resources online that could be of use:
* Information on reviews
* Article on preparing a research protocol
* Information on consent forms
* Confidentiality and anonymity
Application for Research with Human Subjects (PDF document)
IRB Committee email: firstname.lastname@example.org
IRB Committee Meeting Dates for Fall 2018:
**If you have a full committee review, 1) your proposal must be submitted at minimum 14 days before the scheduled meeting, 2) you must attend the scheduled meeting. Failure to comply with either condition will delay review of your proposal**